The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial

Who is this study for? Adults undergoing a total thyroidectomy without previous neck surgery
What treatments are being studied? Autofluorescent detection+Indocyanine green
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

* Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. * The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. * Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. * Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. * This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All adult patients undergoing a total thyroidectomy without previous neck surgery.

Locations
Other Locations
Belgium
Onze Lieve Vrouw Hospital
RECRUITING
Aalst
Contact Information
Primary
Klaas Van Den Heede, MD
klaasvandenheede@hotmail.com
0032472893861
Backup
Sam Van Slycke, MD, PhD
sam.van.slycke@olvz-aalst.be
003253724506
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 300
Treatments
Experimental: Autofluorescent detection and injection of indocyanine green
Drug: indocyanine green (ICG)~Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands.
Placebo_comparator: Control group
Gold standard of visual identification and evaluation of viability.
Related Therapeutic Areas
Sponsors
Leads: Onze Lieve Vrouw Hospital

This content was sourced from clinicaltrials.gov